510(k) K860557
K860557 is an FDA 510(k) premarket notification submitted by Health Research, Inc. for the device "LATEX R. TYPHI". The FDA issued a decision of Substantially Equivalent on April 21, 1986. The device falls under product code GPM (Antiserum, Murine Typhus Fever), a Class I device regulated under 21 CFR 866.3500. Health Research, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1986
- Date Received
- February 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Murine Typhus Fever
- Device Class
- Class I
- Regulation Number
- 866.3500
- Review Panel
- MI
- Submission Type